The Biopharmaceutical industry is currently facing raw material lead time challenges. Conserving chromatography resin usage in downstream unit operations is becoming increasingly important in order to preserve accelerated delivery of GMP drug substance batches used in first time in human clinical studies. Repetitive Batch Chromatography (RBC) couples smaller Protein-A column volumes with faster, more frequent cycles to increase resin productivity compared to more conventional capture column chromatography. By optimizing residence time, lower bed heights can be employed whilst maintaining column diameter for consistent performance across scales. A logical decision tree is presented that identifies which processes are suitable candidates for RBC whilst considering project and facility constraints. In addition, process performance data is presented comparing both RBC and conventional processing methods for an accelerated early phase mAb, illustrating the use of the decision tree.

Maximising protein A resin productivity in a material constrained industry through use of repetitive batch chromatography

ACS Spring 2022

The official archive and repository for all ACS Meetings & Expositions abstracts and select posters or presentations.